EUCTR2007-005011-25-ES进行中（未招募）不适用
A prospective, randomised, double-blind, placebo-controlled, parallel-group, international multicentre phase III trial of PI-88 in the adjuvant treatment of post-resection hepatocellular carcinomaEstudio Fase III, internacional, multicéntrico, prospectivo, aleatorizado, doble-ciego y controlado con placebo, de grupos paralelos de PI-88 en el tratamiento adyuvante de carcinoma hepatocelular post-resección (Pathway) - PATHWAY
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Histologically-proven hepatocellular carcinoma with curative resection performed within 4-6 weeks prior to randomisation and confirmed by negative follow-up chest and abdominal CT scans and abdominal MRI scan
- •2. Age =18 years
- •3. Written, signed and dated informed consent to participate in study
- •4. Able and willing to meet all protocol-required treatments, investigations and visits. This must include the ability for the subject to comply with daily self-administration of a subcutaneous injection, or reliable means for injections to be administered by a dependable third party such as a relative or caregiver.
- •5. ECOG performance status 0 to 2
- •6. Child Pugh classification A or B
- •7. ALT & AST within 2.5 times upper limit of normal (ULN)
- •8. Total bilirubin within 1.5 times upper limit of normal (ULN)
- •9. Platelet count = 100 x 109 cells / litre
- •10. PT-INR less than 1.3 times upper limit of normal (ULN)
- •11. aPTT within normal range
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any evidence of tumour metastasis or co-existing malignant disease
- •2. Any prior history of malignant disease, except:-
- •(a) Non-invasive, non-melanomatous skin cancer
- •(b) Treated in-situ cancer of the cervix
- •3. Any prior recurrence of HCC or any liver resection prior to the most recent procedure
- •4. Clinically significant non-malignant disease. Subjects who have experienced post-operative complications of liver resection may be enrolled providing that such complications are fully resolved at the time of screening.
- •5. Significant laboratory abnormalities including, but not limited to:-
- •(a) Total white blood cell (WBC) count < 2.3 x 109 / litre (<2,300 /mm3)
- •(b) Total neutrophil count < 1.5 x 109 / litre (1,500 /mm3)
- •(c) Serum creatinine > 1.5 times upper limit of normal (ULN)
- •6. History of prior HCC therapy including, but not limited to, radiofrequency ablation, chemoembolization, chemotherapy, radiotherapy, molecular targeting agents, vaccines, liver transplantation or surgical resection prior to the most recent
- •hepatectomy, at any time prior to screening
- •7. History of allergy and / or hypersensitivity and / or other clinically significant adverse drug reaction to heparin or other anti-coagulant agents
- •8. History of immune-mediated thrombocytopaenia or other platelet abnormalities or other hereditary or acquired coagulopathies, or laboratory evidence of anti-heparin
- •antibodies, or any previous history of having tested positive to anti-heparin antibodies
- •9. Concomitant use of aspirin (>150mg / day), non-steroidal anti-inflammatory drugs (except COX-2 selective inhibitors), vitamin K antagonists (other than low-dose prophylactic use), heparin within two weeks prior to randomisation, or other
- •anti-platelet drugs (e.g. abciximab, clopidogrel, dipyridamole, ticlopidine and tirofiban). Low-dose aspirin (=150mg / day) and low-dose prophylactic vitamin K antagonists (e.g. warfarin =1mg / day) are permitted as concomitant medications.
- •10. History of allergic, anaphylactic or other significant adverse reaction to radiographic contrast media (iodinated or noniodinated).
- •11. Known seropositivity to the human immunodeficiency virus (HIV).
- •12. Women who are pregnant or breast-feeding, or women of child-bearing potential who are unable or unwilling to practice a highly effective means of contraception
- •13. Active substance abuse, including alcohol, which, in the opinion of the investigator, risks impairing the ability of the subject to comply with the protocol
- •14. Current participation in any other clinical study or research project which involves administration of a pharmaceutical product or experimental treatment, or which involves protocol-specified laboratory tests, imaging studies or other investigations
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